Biofrontera and Bipharma sign exclusive marketing and distribution agreement for Ameluz® for the Benelux
(Thomson Reuters ONE) -
Biofrontera AG /
Biofrontera and Bipharma sign exclusive marketing and distribution agreement for
Ameluz® for the Benelux
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The issuer is solely responsible for the content of this announcement.
Leverkusen, Germany - Biofrontera Pharma GmbH and Bipharma B.V., Almere, The
Netherlands, announced that they have signed an agreement whereby Bipharma will
obtain exclusive rights to market and distribute Biofrontera's new prescription
product, Ameluz® (5-aminolevulinic acid) in The Netherlands, Belgium and
Luxembourg. In December 2011, the European Commission approved Ameluz® for the
treatment of actinic keratosis in the European Union. Actinic keratosis is a
superficial, UV-light induced skin cancer that affects the upper skin layer (the
epidermis).
In return for exclusive marketing rights in Benelux, Biofrontera receives an
immediate cost compensation of ? 100,000 plus a very significant share of all
net revenues of Ameluz® generated by Bipharma. Biofrontera will remain
responsible for the regulatory approval, manufacturing and quality control of
the product while Bipharma will be responsible for all aspects of
commercialization in the Benelux countries. Both companies will work together on
pharmacovigilance (drug safety). Bipharma has accepted the obligation to launch
Ameluz® in The Netherlands no later than November 1, 2012, and to devote a pre-
agreed marketing and sales budget to Ameluz®.
Dr. Robert Veldman, CEO of Bipharma: "Due to its increasing prevalence and the
growing awareness actinic keratosis is already the reason for an important
portion of all visits to dermatologists. Bipharma is highly recognized in the
field of dermatology in the Benelux. We are proud to be able to offer such an
excellent PDT drug to the dermatologists in our region."
Prof. Hermann Lübbert, CEO of Biofrontera, comments on the agreement: "Following
our agreements with Allergan for Spain and Desitin for Scandinavia, we have
selected for the Benelux a smaller, locally concentrated company. For several
years we have established close contacts to Bipharma and have been very
impressed by the pragmatic and disease-oriented way in which Bipharma has grown
the sales of their products, a large part of which were in dermatology.
Therefore we are happy that Bipharma has now become a member of the group of
companies that will be marketing Ameluz® throughout Europe, each one of them
adding their particular strengths."
-- ENDS --
Background
Ameluz® (developed as BF-200 ALA gel) was approved by the European Commission
for the treatment of actinic keratosis in December 2011. The product is a
photosensitizing agent used in photodynamic therapy (PDT). The registration was
based on two phase III clinical trials involving more than 693 patients
suffering from four to eight independent actinic keratosis lesions. These
studies demonstrated that PDT using Ameluz® and narrow spectrum LED light
sources led to the complete removal of all actinic keratosis lesions at 12 weeks
after the last PDT in 85% and 87% of patients[1]. The treatment can be repeated
after three months if residual lesions remain. In a direct head to head
comparison against a cream containing 16% methyl-aminolevulinate (MAL), 85% of
the patients were totally cleared from all lesions with Ameluz® while the MAL
cream cleared only 68% of the patients when LED light sources were used[1]. As
with any PDT, the most common side effects occurred at the site of application
and included irritation, erythema, pain, pruritus and oedema[1].
Other treatment options have lower clinical efficacy, longer-lasting side
effects and many result in visible scars or pigmentation changes[2]. Actinic
keratosis is mostly seen in fair-skinned people on skin areas that have had
long-term sun exposure[3]. The condition affects about 10% of the entire
Caucasian population world-wide[4]. About 5-20% of patients with actinic
keratosis lesions develop malignant and potentially fatal squamous cell
carcinomas[5].
About Biofrontera
Biofrontera Pharma GmbH is a wholly-owned subsidiary of Biofrontera AG. The
Biofrontera group aims at attending and treating the skin, recognizing the
aesthetic needs of a person's visual reflection. Biofrontera is listed at the
regulated market of the Düsseldorf stock exchange under the symbol B8F and the
ISIN number DE0006046113.
www.biofrontera.com
This press release contains forward-looking statements based on the currently
held beliefs and assumptions of the management of Biofrontera AG, which are
expressed in good faith and, in their opinion, reasonable. Forward-looking
statements involve known and unknown risks, uncertainties and other factors,
which may cause the assumptions expressed or implied in this press release to be
faulty. Given these risks, uncertainties and other factors, recipients of this
document are cautioned not to place undue reliance on the forward-looking
statements. Biofrontera AG disclaims any obligation to update these forward-
looking statements to reflect future events or developments.
References
[1] Ameluz® Summary of Product Characteristics; www.ema.europa.eu
[2] Lawrence, N., Cox, S. E., Cockerell, C. J., Freeman, R. G., & Cruz, P. D.
Jr., 1995, Arch.Dermatol, 131, 176-181.
Lebwohl, M., Dinehart, S., Whiting, D., Lee, P. K., Tawfik, N., Jorizzo, J.,
Lee, J. H., & Fox, T. L., 2004, J Am.Acad.Dermatol, 50, 714-721.
Stockfleth, E. & Kerl, H., 2006, Eur. J. Dermatol. 16, 599-606.
[3] Salasche SJ., 2000, Am Acad Dermatol, 42, 4-7.
[4] Frost, C. A. & Green, A. C., 1994, Br J Dermatol, 131, 455-464.
Memon, A. A., Tomenson, J. A., Bothwell, J., & Friedmann, P. S., 2000, Br J
Dermatol, 142, 1154-1159.
[5] Braathan LR, Szeimes RM, Basset-Seguin N et al., 2007 J Am Acad Dermatol,
56, 125-143.
For further information please contact:
Anke zur Mühlen
Director PR/IR
+ 49 214 87632 0
+ 49 214 87632 90
a.zurmuehlen(at)biofrontera.com
Biofrontera AG
Hemmelrather Weg 201
D- 51377 Leverkusen, Germany
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Biofrontera AG via Thomson Reuters ONE
[HUG#1600070]
Unternehmensinformation / Kurzprofil:
Datum: 04.04.2012 - 09:33 Uhr
Sprache: Deutsch
News-ID 131931
Anzahl Zeichen: 7569
contact information:
Town:
Leverkusen
Kategorie:
Business News
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